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Use of risk stratification to target therapies in patients with recent onset arthritis; design of a prospective randomized multicenter controlled trial
BMC Musculoskeletal Disorders, 06/23/09

Claessen SJJ et al. - First rheumatological study for treatment in early arthritis based on a prediction rule where treatment will be stratified according to the probability of persistent arthritis has entered the clinical trial. Different combinations of treatment per stratum will be evaluated; treatment will start early, and patients will not need to meet the ACR-criteria for rheumatoid arthritis.

Methods

Randomized trial is currently being performed to determine which induction therapy is most effective in the very early stage of persistent arthritis
Induction therapy will be based on a prediction model that predicts pts' propensity for persistent arthritis
Pts ≥18 yrs with recent-onset arthritis (n=810) are being stratified according to the likelihood of their developing persistent arthritis
Following therapies are planned:
- Pts with a high probability persistent arthritis: combination of DMARDs vs monotherapy MTX
- Pts with an intermediate probability of persistent arthritis: DMARDs of various intensities
- Pts with a low probability: NSAIDs, hydroxychloroquine and a single dose of corticosteroids
If disease activity is not sufficiently reduced, treatment will be adjusted according to a step-up protocol
If remission is achieved for at least 6 mo, medication will be tapered off
Pts will be followed up every 3 mo over 2 yrs

Results